Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans

A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of ASEA on Energy Expenditure and Fat Oxidation in Humans

To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis: consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo control (salt water, same dietary intake).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: ASEA water; Dietary supplement: Salt Water

Detailed Description

The ASEA beverage is a special oral formulation produced from a pure saline solution containing 123 mg sodium and 129 mg chloride per 4 oz. serving. A proprietary electrolytic and catalytic process rearranges the salt water solution to mimic the redox signaling molecular composition of the native salt-water compounds found in and around human cells. Data obtained thus far, suggests the possibility that consumption of the ASEA beverage may increase energy expenditure and thus be beneficial for the treatment of obesity, however, this has not been assessed in human clinical studies. To this end, we will measure the effects of ASEA consumption on energy expenditure by indirect calorimetry using the indirect room calorimeter at the University of North Carolina (UNC) Nutrition Research Institute.

The primary outcome measures will be the change in 24-h energy expenditure and respiratory quotient in response to ASEA consumption. The secondary outcome variables will include changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship to changes in energy expenditure in response to consumption of ASEA.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Kannapolis, North Carolina, United States, 28081
      • Nutrition Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• woman
• postmenopausal
• healthy
• age 50-65
• BMI 25-35 kg/m²
• exercise less than 150 minutes per week
• weight neutral for past 6 months

Exclusion Criteria:

• smoker
• exercises more than 150 minutes per week
• abuses drugs or alcohol
• vegetarian
• taking herbal supplements, attention deficit hyperactivity disorder (ADHD) medication or thyroid medication
• taking beta-blockers, steroidal anti-inflammatory medication
• taking pseudoephedrine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ASEA water; Subjects to consume 4-ounces of ASEA water at 9:00 am before breakfast and 4-ounces of ASEA water at 10:15 pm prior to bedtime. 24-h resting energy expenditure and RQ to be measured.	Dietary supplement: ASEA water; Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of ASEA water or breakfast, and at 11 am after consumption of ASEA water and breakfast. Subjects will receive a second portion of ASEA water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.
Placebo Comparator: Salt water; Subjects to consume 4-ounces of salt water at 9:00 am before breakfast and 4-ounces of salt water at 10:15 pm prior to bedtime. 24-h resting energy expenditure and RQ to be measured.	Dietary supplement: Salt Water; Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of salt water or breakfast, and at 11 am after consumption of salt water and breakfast. Subjects will receive a second portion of salt water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Energy Expenditure	Changes in 24-h resting energy expenditure and respiratory quotient (RQ) in response to ASEA or control salt water to be measured by indirect calorimetry in the room indirect calorimeter at the UNC Nutrition Research Institute.	24-hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Hormones	Relevant peptide hormones and nor-epinephrine/epinephrine will be assessed before consumption of ASEA (or control water) before breakfast (9:00 am) and after consumption of ASEA (or control water) after breakfast (11:00 am).	0900 and 1100 hours

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Andrew G Swick, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Obesity; Overweight; energy expenditure; Over nutrition; nutrition disorders; metabolic rate
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 12-1675

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No